Failure mode, effects and criticality analysis research on human factors in clinical PET application / 中华放射医学与防护杂志

ABSTRACT

Objective To identify the steps with potentially higher risk through the analysis of human factors in clinical PET application so as to provide the efficient measures to reduce the risk of potential exposures.Methods The basic data were obtained through field investigation, questionnaire,failure mode, risk identification, FMECA and expert's evaluation, with statistical analysis made.Comparison was made of the relative risk values of automatic encapsulation equipment and manual encapsulation ones.Results The 10 steps with potentially higher risks were identified through analyzing human factors of clinical PET application, of which 8 occurred in the phase of chemical synthesis.The measures to control risk were addressed for the steps with higher risk.The results show that the relative risk value of the clinical process with automatic encapsulation equipment was 2.28 ± 0.99 and the one with manual encapsulation equipment was 3.20 ± 2.01 ( t = 2.56, P ＜ 0.05 ), with the latter being 76% of the former.Conclusions Failure mode and FMECA are effective in risk evaluation of clinical PET application, which can provide important basis for risk control.